First New Drug for Treatment of Lupus on Target for Approval Next Year

First New Drug for Treatment of Lupus on Target for Approval Next Year

For the first time in 50 years, scores of African Americans diagnosed with lupus could find relief from a new drug scheduled to hit the market late-next year, officials said.

The drug, Benlysta (belimumab), developed by Human Genome Sciences (HGS), based in Rockville, Md., found in the second of two pivotal Phase 3 trials (BLISS-76) that patients showed a significant improvement while receiving 10 mg/kg of the drug, compared with those taking a placebo plus standard care during the 52-week trial. Additionally, findings showed that the drug was generally well tolerated.
The news is promising for African American women, who are three times more likely as white women to develop the disease, experts say. Black women also tend to get the disease at younger ages and have more severe symptoms than their white counterparts.

“The results from this second pivotal Phase 3 trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients with lupus who have had no new treatment in 50 years,” said Carlo Russo, M.D., senior vice president at GlaxoSmithKline, which is working with HGS on the product. “We look forward to continuing our collaboration with HGS in order to bring this important medicine to patients.”

GlaxoSmithKline will submit marketing applications at the beginning of the year, following discussions with regulatory officials around the globe.

Lupus is a chronic and sometimes fatal autoimmune disorder that affects more than 1.5 million Americans, mostly women of childbearing age, rendering some disabled, according to the Lupus Foundation of America. Patients can develop fatigue, cardiovascular disease, kidney disorder, kidney failure, arthritis and rashes. Symptoms are generally treated with steroids. Benlysta, on the other hand, allows doctors to minimize the dose of steroids, which results in massive weight gain, high blood pressure, diabetes and other side effects.
Tagged as: african american women, AfricanAmericanWomen, cardiovascular, diabetes, glaxosmithkline, high blood pressure, HighBloodPressure, human genome sciences, HumanGenomeSciences, kidney, lupus, lupus new treatment, LupusNewTreatment

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